Recall MonitorHealth Products
DLP Cardiac Vents & Sumps
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: DLP Cardiac Vents & Sumps
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| DLP Cardiac Vents & Sumps | More than 10 numbers, contact manufacturer. | 12115 |
| DLP Cardiac Vents & Sumps | More than 10 numbers, contact manufacturer. | 12110 |
| DLP Cardiac Vents & Sumps | More than 10 numbers, contact manufacturer. | 12113 |
Issue
Since March 2024, there has been an increase in complaints reported for the DLP malleable left heart vent catheter for the catheters resisting shape retention when being bent. The catheters are intended to be malleable and retain a bend in the shaft. It was determined that the primary supplier updated their specification to remove annealing process to attain tensile strength listed in ASTM1313-18.